N/A
N=85
Breathing Meditation Intervention for Post Traumatic Stress Disorder
Stress Disorders, Post-Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT02366403 ↗Enrolled (actual)
85
Serious AEs
1.2%
Results posted
Apr 2021
Primary outcome: Primary: Change in PTSD Checklist (PCL) — -5.6; -6.8; -4.8; -6.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SKY meditation (Behavioral); CPT-C (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in PTSD Checklist (PCL) |
-5.6; -6.8; -4.8; -6.8; -4.4; -6.2 | — |
| SECONDARY Change in Beck Depression Inventory II (BDI-II) |
-6.1; -3.6; -4.7; -2.8; -5.6; -4.5 | — |
| SECONDARY Change in Positive and Negative Affect Schedule (PANAS) |
2.5; 0.3; 1.3; -1.3; -0.1; 0.4 | — |
Summary
Post traumatic stress disorder (PTSD) is a condition that develops as a result of exposure to a traumatic event. The purpose of this study is to determine whether a breathing meditation technique (Sudarshan Kriya Yoga; SKY) provides a treatment benefit that is as effective as the standard intervention. Patients' PTSD symptoms will be monitored before treatment, at the end of treatment, one month after treatment and 12 months after treatment.
Eligibility Criteria
Inclusion Criteria
- Veteran from any conflict era
- Symptoms of Posttraumatic Stress Disorder measured during study screening (scoring ≥38 on the PCL-5)
Exclusion Criteria
- planning on starting a new course of behavioral therapy during the trial
- started new medication for PTSD within 8 weeks of the study screening
- participation in another study
- mania or psychosis within the past 6 months
- suicidal or homicidal intent within the past 60 days
- substance dependence (other than nicotine) within the past 30 days,
- seizure disorder
- severe traumatic brain injury
Data sourced from ClinicalTrials.gov (NCT02366403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.